Biotechnology Breakthrough: First Wearable Device That Continuously Tracks COVID-19 Symptoms

Biotechnology  and medical researchers from Northwestern University and Shirley Ryan AbilityLab in Chicago have developed an innovative wearable device and are creating a set of data algorithms specifically tailored to catch early signs and symptoms associated with COVID-19 disease and to monitor patients as the illness progresses.


Credit: Northwestern University 
 
The new device capable of being worn 24/7, produces continuous streams of data and uses artificial intelligence to uncover even the most subtle, but potentially life-saving, insights. Filling a vital data gap, it continuously measures and interprets coughing and respiratory activity in ways that are impossible with traditional monitoring systems.
 
Conceived in an engineering laboratory at Northwestern and using custom algorithms created by Shirley Ryan AbilityLab scientists, the devices are currently being used at Shirley Ryan AbilityLab by COVID-19 patients and the healthcare workers who treat them. About 25 affected individuals began using the devices two weeks ago. They are being monitored both in the clinic and at home, totaling more than 1,500 cumulative hours and generating more than one terabyte of data.
 
The wearable monitoring device  the size of a postage stamp besides being soft, flexible, wireless and thin, sits comfortably just below the suprasternal notch ie the visible dip at the base of the throat. From this location, the device monitors coughing intensity and patterns, chest wall movements (which indicate labored or irregular breathing), respiratory sounds, heart rate and body temperature, including fever. From there, it wirelessly transmits data to a HIPAA-protected cloud, where automated algorithms produce graphical summaries tailored to facilitate rapid, remote monitoring.
 
Dr John A. Rogers from Northwestern who led the technology development told Thailand Medical News, "The most recent studies published in the Journal of the American Medical Association suggest that the earliest signs of a COVID-19 infection are fever, coughing and difficulty in breathing. Our device sits at the perfect location on the body the suprasternal notch to measure respiratory rate, sounds and activity because that's where airflow occurs near the surface of the skin. We developed customized devices, data algorithms, user interfaces and cloud-based data systems in direct response to specific needs brought to us by frontline healthcare workers. We are fully engaged in contributing our expertise in bioelectronic engineering to help address the pandemic, using technologies that we are able to deploy now, for immediate use on actual patients and other affected individuals. The measurement capabilities are unique to this device platform as they cannot be accomplished using traditional watch or ring-style wearables that mount on the wrist or the finger."
 
Dr Arun Jayaraman, a research scientist at Shirley Ryan AbilityLab, who is leading the algorithm development added, "We anticipate that the advanced algorithms we are developing will extract COVID-like signs and symptoms from the raw data insights and symptoms even before individuals may perceive them. These sensors have the potential to unlock information that will protect frontline medical workers and pati ents alike informing interventions in a timely manner to reduce the risk of transmission and increase the likelihood of better outcomes."
 
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Home Or Hospital Continuous Monitoring
 
The emerging ways that COVID-19 affects the body seem to get stranger and stranger. Many patients' symptoms fully disappear before they suddenly and unexpectedly begin deteriorating sometimes within a matter of hours. Other patients have recovered and tested "negative" but later test "positive" again.

The many unknowns underscore the need for continuous patient monitoring to ensure that physicians can intervene at the slightest sign of trouble. The Northwestern and Shirley Ryan AbilityLab teams' device provides around-the-clock monitoring for COVID-19 patients and those exposed to them.
 
Dr Mark Huang, a physician at Shirley Ryan AbilityLab, who has worn the sensor said, "Having the ability to monitor ourselves and our patients and being alerted to changing conditions in real time, will give clinicians a new and important tool in the fight against COVID-19. The sensor also will offer clinicians and patient’s peace of mind as it monitors COVID-like symptoms, potentially prompting earlier intervention and treatment."
 
The monitoring device can clinically observe hospitalized patients and then be taken home to continue 24/7 supervision. The real-time data streaming from patients gives insights into their health and outcomes that is currently not being captured or analyzed by traditional monitoring systems.
 
Dr Rogers added, "So far, nobody has ever collected this type of data before. Earlier detection is always better and our devices provide important and unique capabilities in that context. For patients who have contracted the disease, the value is even clearer, as the data represent quantitative information on respiratory behavior, as a mechanism to track the progression and/or the effects of treatments."
 
Dr Jayaraman added, "This opens up new telemedicine strategies as we won't have to bring in patients for monitoring. Physicians can potentially review the patients' data for hours, days or weeks, immediately through a customized graphical user interface to a cloud data management system that is being set up for this purpose, to see an overall image of how the patient is doing."
 
Although the wearable device is currently unable to measure blood oxygenation levels, which is an important component of lung health, the team plans to incorporate this capability in its next round of devices.
 
An Alert System For Those Most At-Risk 
 
The wearable device can monitor the progress of COVID-19 patients and also it could also provide early warning signals to the frontline workers who are most at risk for catching this remarkably infectious disease. The device offers the potential to identify symptoms and to pick up trends before the workers notice them, thereby providing an opportunity to engage in appropriate precautionary measures and to seek further testing as quickly as possible.
 
Dr Jayaraman added, "People with obvious, severe symptoms are going to the hospital, being tested or being told to self-isolate. For those who have symptoms they perceive as mild or seasonal allergies, there is no warning system. They could be in contact with others and unknowingly spread infection."
 
Monitor Efficacy Of New Treatment Protocols
 
As medical researchers rush for a COVID-19 cure, physicians have been trying exploratory, sometimes unproven, treatments to help their patients. This is another area where the new device can play a role.
 
Dr Rogers said, "Early reports of certain proposed treatments suggest that they can eliminate coughing symptoms more quickly than a placebo. Nobody, however, is quantifying certain key symptoms, such as coughing its duration, frequency, amplitude, sounds, etc. Our device allows for precision measurement of this essential, yet currently unquantified, aspect of the disease."
 
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The sensor package could in the future help researchers and physicians quantify which therapeutics are working best.
 
Dr Rogers added, "At the simplest level, our systems allow assessments based on data, in a quantitative way, without relying on human judgment of whether a patient is coughing more or less.”
 
Initially Developed For Stroke Patients
 
The novel wearable monitoring device builds on recent research from a collaboration between Dr Rogers' and Dr Jayaraman's labs, first published on the cover of the February 2020 issue of Nature Biomedical Engineering, with a focus on monitoring swallowing and speech disorders in patients recovering from stroke. These sensors work by precisely measuring vibratory signatures from the throat and chest. By measuring vibrations rather than acoustics, the team avoids noise from background sounds and it bypasses privacy issues.
 
As a result of tremendous requests and inquiries from the medical community, Dr Rogers and Dr Jayaraman realized they could use this technology to measure the vibratory signatures of COVID-like symptoms, including chest wall movements and cough.
 
Dr Jayaraman's team is developing custom signal processing and machine-learning algorithms to train the device how to recognize coughs in the data.
 
Dr Jayaraman further commented, "As the algorithm becomes smarter, our hope is that it will begin to discriminate among which coughs are COVID-like and which are from something more benign. The most basic approach, already deployed on COVID-19 patients and health care workers, simply counts coughs and their intensity."
 
The developers say that more advanced analytics packages will be available within the next few weeks.
 
Rapid Development And Production
 
As a result of a generous gift from Northwestern University trustees Kimberly K. Querrey and Louis A. Simpson, Dr Rogers and his team were able to respond quickly to requests for devices. Leveraging a set of manufacturing tools available in the new Simpson Querrey Biomedical Research Building in Chicago, the team is already producing dozens of devices per week.

Dr Rogers estimates that his team could produce up to hundreds of devices per week, all in house, largely bypassing the need for external vendors and complex supply chains.
 
Dr Querrey said "Quickly developing new technologies internally has never been more crucial. This work proves the power of STEM and why it's so critical to the University and beyond to have world-class researchers like John. I am so proud of John and his team, while working remotely, for thinking outside the box and using their collaborations to help protect our healthcare workers. We are excited to be able to develop these devices within the University and get them in the hands of those needing them most. The ability to measure vibratory signatures could really help with early detection of COVID-19."
 
Dr Rogers Added, "This crucial philanthropic support has allowed us to develop and deploy the devices and an associated software infrastructure almost immediately, within days, after we started receiving requests from the medical community without waiting for external vendors, most of which are mostly shut down with the stay-at-home orders. In this way, we avoid already-stressed supply chains. We just do it ourselves."
 
Extremely Comfortable And User Friendly
 
Sometime in mid-March, Kelly McKenzie felt foggy and developed a low-grade headache. Having recently returned from a work-related trip overseas, she assumed it was jetlag. But as her symptoms progressed to include cough and congestion, she started to worry. Although her symptoms were not severe enough to seek COVID-19 testing, she knew she should self-isolate.
 
McKenzie, who is a research physical therapist at Shirley Ryan AbilityLab said, "Between my international travel and the symptoms, my director and I decided it was best for me to stay home from work, so I wasn't bringing anything contagious into the hospital."
 
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She joined the pilot study to test the device and train the algorithm with her symptoms. After wearing the sensor around the clock for a week, she was amazed by the comfort of the soft silicone material and ease of use. Wearers simply charge the device, put it on and it immediately begins to work, streaming real-time data to a smartphone or tablet.
 
She added, "When you first put it on, you can feel it just because it's new and different. But after you have worn it for a while, you don't even notice it."

As the device is fully encased without wires, electrodes, charge ports or removable batteries, the device can be worn while exercising or in the shower. It turns out this also is important for sterilization and reuse.
 
Dr Rogers added, "This is absolutely critical for use in the context of this extremely contagious disease. Because it is fully sealed in a soft biocompatible silicone material, it can be completely immersed in alcohol, and then exposed to a gas-based system for rigorous sterilization. If there were exposed regions, or plugs or ports or other physical interfaces, the device would not be relevant for this application."
 
Next Plans
 
In the next months, the Northwestern and Shirley Ryan AbilityLab teams will continue collecting patient data to strengthen their algorithms through deployments both in the clinic and at home. They also are responding to other requests for access to the technology, across the medical complex in Chicago. Additional deployments are starting now.
 
Dr Rogers and Dr Jayaraman also are examining data from patients recovering from COVID-19, attempting to determine when they are no longer contagious. Some of the patients wearing the device have been dismissed from the acute-care hospital and are rehabilitating at Shirley Ryan AbilityLab. In the future, this device could help determine whether post-COVID patients still have minor, perhaps imperceptible symptoms.
 
Dr Rogers hopes the device will not just tell physicians how to best treat COVID-19 but also inform researchers about the nature of the virus itself.
 
He added, "The growing amount of information and understanding around COVID-19 as a disease will be critically important to containing and treating the current outbreak as well as those that might occur in the future. We hope, and we believe, that these devices may help in these efforts by identifying and quantifying characteristics and essential features of cough and respiratory activity associated with this disease."
 
To further accelerate the deployment of this device, the team recently launched a lean engineering-centric company, Sonica Health, based on intellectual property jointly developed by Northwestern and the Shirley Ryan AbilityLab and licensed through Northwestern's Innovation and New Ventures Office. Exploring use of the device for the COVID-19 response is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
 
The developers hope that the wearable medical devices will be mass produced and available throughout the US, Canada, Europe, Australia, India, Japan and Singapore in at least 3 months’ time.  
 
For more biotechnology breakthroughs, keep logging to Thailand Medical News.
 
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